1. Field of the Invention
The present invention relates to the field of nasal patches or nasal dilators that assist in keeping the exterior nasal passages open to assist in breathing and/or avoiding snoring. A process, structure, and composition of elements which assist in providing necessary or useful properties for the nasal dilator are provided.
2. Background of the Art
Nasal Dilators
Nasal dilators for opening nasal passages are known in the art. These nasal dilators are generally strips fabricated from multiple and separate components including a structural material such as a woven material having an adhesive on one side for adhering to the nose and surrounding skin, a resilient member, and a backing. When adhered to the nose, the nasal dilators are designed to affect the opening of the nasal passages, providing relief for a wearer who may be experiencing difficulty in breathing or seeking to increase air flow through the nasal passages.
To accomplish this effect, prior art nasal dilators generally rely on the elastic or resilient member's ability to stabilize the nasal passages and reduce or prohibit nasal passage collapse or closing during breathing. When the strip is positioned across the nose, the resilient members operate as flexible, spring-like bands which desire to return to a more planar position, resulting in the lifting of the outer wall tissue of the nasal passage. As a result of this lifting, the collapsing or closing of the nasal passage openings during breathing is reduced.
As shown in FIG. 1, a typical prior art nasal dilator 100 is generally sized to fit across the nose of the wearer so as to engage the outer wall tissue of the left and right nasal passages. As shown in FIGS. 2-3, these nasal dilators 100 may include an elongated base substrate layer 30 having a pair of longitudinal sides, a pair of transverse ends and top and bottom surfaces thereon. The bottom surface of the base substrate layer 30 generally contains an adhesive layer 32 for permitting easy attachment to the wearer's skin. Nasal dilators of the prior art often utilize a separately manufactured resilient member 60 attached to the base substrate layer 30 during assembly. This resilient member 60 provides a gentle expanding force to the nasal wall tissue when the dilator is adhesively attached to the nose. Typically, the dilator 100 further includes a top or backing layer 40. The top or backing layer 40 and resilient member 60 are generally bonded to the substrate base layer 30, for example, by using pressure sensitive adhesive layers 42 and 62 during assembly.
In some embodiments, nasal dilators of the prior art further include, for example, an aromatic substance 50, such as a fragrance or aromatic stimulant or medication, disposed on a portion of the dilator so as to be inhaled through the nose of the wearer during breathing. Additionally, a substance that can be transdermally provided to the patient to effect a local biochemical result may also be included. The substance can be added to the bottom surface of the dilator 100, with, or without an aromatic substance.
Finally, a release liner or release paper strip 10, such as polymeric coated (e.g., silicone or fluorinated polymer) or wax coated kraft paper, is generally added over the pressure sensitive adhesive layer 32 prior to packaging the dilator 100 for sale.
Due to this design, a typical prior art nasal dilator requires using separate multiple components, manufacturing each component in a separate step, and then assembling the device in a multiple step process. Furthermore, the separate resilient member used in the typical nasal dilator tends add bulk to the nasal dilator.
U.S. Pat. No. 5,533,503 (Doubek at al.) describes a nasal dilator composed of a separate base substrate material, multiple separate resilient members comprised of plastic materials, separate flexible strips of adhesive materials, and a separate top or backing material. Accordingly, the manufacture of the nasal dilator is described as requiring the interface adhesive materials to be first laminated to the resilient band members, and then the top material laminated to the base material over the resilient band member.
U.S. Pat. No. 5,890,486 (Mitra) describes a multiple component nasal dilator having a separate base or substrate material, an intermediate segment, single or multiple resilient band members, adhesive strips, a thermal element, and a top or backing material. The resilient band members are described as being metal and/or plastic, and preferably industrial grade, oriented bi-axially oriented polyester that is approximately 2 mm to 8 mm wide and 0.25 mm thick. In alternative embodiments, the metal or plastic resilient band members are described as being formed within the base or top material through an extrusion process. The nasal dilators are described as being manufactured by bonding the base material to the top material, thereby encapsulating the resilient members, strips of adhesive materials, and thermal element in a unified structure.
U.S. Pat. No. 6,244,265 (Cronk et al.) describes a multiple component nasal dilator wherein separate substrate materials, resilient members, and backing materials are adhesively joined together as they are fed into an overlapping position in a die or roller. Adhesive layers are used to join the backing layer, resilient member and elongated substrate together prior to die-cutting to form the final periphery of the dilator. The described nasal dilators further include medications and/or fragrances disposed in or on the backing and/or substrate material.
U.S. Pat. No. 6,769,429 (Benetti) discloses a nasal dilation device that includes a single, integral strip of flexible resilient material having a central portion for positioning over and in engagement with the top of an individual nose and opposed end portions including independently flexible upper and lower finger elements diverging from one another. The resilient material is described as a single clear plastic material in a thickness range of from about 0.2 mm to about 0.6 mm. Separate adhesive tape elements overlie the end portions for releasably securing the end portion to opposed sides of the individual's nose.
U.S. Pat. No. 6,694,970 (Spinelli et al.) describes a multi-component nasal dilator that includes a base material having an adhesive on one surface for applying the strip across a human nose and at least one biasing or resilient member attached or embedded in the strip, wherein the biasing or resilient member is fabricated from a material, preferably metal, which exhibits a shape memory effect upon being heated toward a human body temperature, preferably by the heat of the nose. The biasing or resilient member is described as having a shape upon being heated toward the human body temperature that results in the material reverting to austenite and then recovering its previous shape, which biases the nasal passages of the human nose toward an open position.
U.S. Pat. No. 7,114,495 (Lockwood) describes a multiple component, multi-layer nasal dilator capable of introducing separating stresses in nasal outer wall tissues having a resilient band member, which is symmetrical with respect to a centerline of the truss that is perpendicular to the long axis of the truss, with a spring rate which continuously diminishes from the centerline to the end surfaces. An adhesive on the end surfaces adhesively engages exposed surfaces of nasal outer wall tissues sufficiently to keep the truss attached to the nasal wall surfaces while subjecting them to the restoring forces. The nasal dilator also includes a top or backing layer, and a cushion layer designed to prevent direct contact between the resilient band member and the skin of the user.